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TOPOTECAN
Overview
What is TOPOTECAN?
Topotecan is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.
The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1-pyrano[3’,4’:6,7]indolizino[1,2-]quinoline-3,14-(4,12)-dione1.25 hydrochloride. It has the molecular formula CHNO.1.25 HCl and a molecular weight of 467.02. Topotecan hydrochloride is soluble in water and melts with decomposition at 213°C to 218°C. As formulated in topotecan injection, topotecan hydrochloride has the following structural formula:
Topotecan Injection is supplied as a sterile, non-pyrogenic, clear, yellow to yellow-green solution at a topotecan free base concentration of 4 mg/4 mL (1 mg/mL) available in single dose vials. Each mL of topotecan injection contains topotecan hydrochloride equivalent to 1 mg of topotecan as free base, 5 mg tartaric acid, NF and water for injection, USP. Hydrochloric acid and/or sodium hydroxide may be used for pH adjustment to pH 2.6 to 3.2.
The solution must be diluted before administration by intravenous infusion.
What does TOPOTECAN look like?
What are the available doses of TOPOTECAN?
Injection: 4 mg/4 mL (1 mg/mL, topotecan free base equivalent) clear, yellow to yellow-green solution in single dose vial for intravenous infusion only following dilution.
What should I talk to my health care provider before I take TOPOTECAN?
How should I use TOPOTECAN?
Topotecan injection is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [].
What interacts with TOPOTECAN?
Sorry No Records found
What are the warnings of TOPOTECAN?
Sorry No Records found
What are the precautions of TOPOTECAN?
Sorry No Records found
What are the side effects of TOPOTECAN?
Sorry No records found
What should I look out for while using TOPOTECAN?
Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan.
What might happen if I take too much TOPOTECAN?
Overdoses (up to 10-fold of the prescribed dose) occurred in patients treated with intravenous topotecan. The primary complication of overdosage is bone marrow suppression. The observed signs and symptoms of overdose are consistent with the known adverse reactions associated with topotecan injection []. In addition, elevated hepatic enzymes and mucositis have been reported following overdose.
One patient received a single dose of 40 mg/mof intravenous topotecan and developed gastrointestinal toxicity, skin toxicity, and myelosuppression leading to septic shock. Another patient received a single dose of 35 mg/mand experienced severe, reversible neutropenia.
There is no known antidote for overdosage with topotecan injection. If an overdose is suspected, monitor the patient closely for bone marrow suppression and institute supportive-care measures (such as the prophylactic use of G-CSF and antibiotic therapy) as appropriate.
How should I store and handle TOPOTECAN?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from light.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.Sodium Iodide I 131 Capsules Therapeutic is supplied in a shielded, plastic vial containing one opaque white gelatin capsule per vial. The capsules are available in strengths ranging from 28 to 3700 MBq (0.75 to 100 mCi) iodine-131 at the time of calibration. The calibration date and the expiration date are stated on the label. Do not use the product after the expiration date.Storage Store at a controlled room temperature of 20° to 25°C (68° to 77°F). Storage and disposal of Sodium Iodide I 131 Capsules Therapeutic should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in 10 CFR 35.300, and to persons who hold an equivalent license issued by an Agreement State.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA. Mammalian cells cannot efficiently repair these double-strand breaks.
Non-Clinical Toxicology
Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan.Olmesartan medoxomil
No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH)/Mg(OH)]. Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Dual Blockade of the Renin- Angiotensin System (RAS)
Do not co-administer aliskiren with Benicar HCT in patients with diabetes (see ). Avoid use of aliskiren with Benicar HCT in patients with renal impairment (GFR <60ml/min).
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
Colesevelam hydrochloride
Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose (see ).
Lithium
Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Monitor lithium levels in patients receiving BENICAR HCT and lithium.
Hydrochlorothiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
Alcohol, Barbiturates, Or Narcotics
Antidiabetic Drugs (oral agents and insulin)
Other Antihypertensive Drugs
Cholestyramine and Colestipol Resins
Corticosteroids, ACTH
Pressor Amines (e.g. Norepinephrine)
Skeletal Muscle Relaxants, Non depolarizing (e.g. Tubocurarine)
Non-steroidal Anti-inflammatory Drugs
Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity of topotecan. Neutropenia is not cumulative over time. Severe myelotoxicity has been reported when topotecan is used in combination with cisplatin [].
Neutropenia
Thrombocytopenia
Anemia
Administer topotecan injection only to patients with a baseline neutrophil count of greater than or equal to 1,500 cells/mmand a platelet count greater than or equal to 100,000/mm. Monitor peripheral blood counts frequently during treatment with topotecan injection. Refer to Section 2.4 for dose modification guidelines for hematological toxicities in subsequent courses. Do not treat patients with subsequent courses of topotecan injection until neutrophils recover to greater than 1,000 cells/mm, platelets recover to greater than 100,000 cells/mm, and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary).
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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